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Multi-institutional Phase I/II Study: Neoadjuvant Chemoradiation With 5-FU (or Capecitabine) and Oxaliplatin Combined With Deep Regional Hyperthermia in Locally Advanced or Recurrent Rectal Cancer


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Rectal Cancer

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Trial Information

Multi-institutional Phase I/II Study: Neoadjuvant Chemoradiation With 5-FU (or Capecitabine) and Oxaliplatin Combined With Deep Regional Hyperthermia in Locally Advanced or Recurrent Rectal Cancer


Inclusion Criteria:



- Age ≥ 18 years

- Histologically confirmed, locally advanced or recurrent (any recurrence of tumor
within the lesser pelvis; resectable or non-resectable) adenocarcinoma of the rectum
(UICC stage IIB-IV); distant oligo-metastases may be present.

- ECOG-performance status < 2

- Sufficient bone marrow function:

- WBC > 3,5 x 10^9/l

- Neutrophil granulocytes > 1,5 x 10^9/l

- Platelets > 100 x 10^9/l

- Hemoglobin > 10 g/dl

- Sufficient liver function: Bilirubin < 2,0 mg%, SGOT, SGPT, alkaline phosphatase, gGT
less than 3 times upper limit of normal

- Serum creatinine < 1,5 mg%, glomerular filtration rate (or comparable test) > 50
ml/min

- Signed study-specific consent form prior to therapy

- Fertile patients must use effective contraception during and for 6 months after study
treatment

- Considered fit for oxaliplatin and 5-FU-containing combination chemotherapy

Exclusion Criteria:

- Pelvic radiotherapy during the last 12 months

- Pregnant or lactating/nursing women

- Drug addiction

- On-treatment participation on other trials

- Active intractable or uncontrollable infection

- Prior or concurrent malignancy (≤ 5 years prior to enrolment in study) except rectal
cancer or non-melanoma skin cancer or cervical carcinoma FIGO stage 0-1 if the
patient is continuously disease-free

- Chronic diarrhea (> NCI CTC-Grad 1)

- Chronic inflammatory disease of the intestine

- Collagen vascular disease

- The presence of congenital diseases with increased radiation sensitivity, for example
teleangiectatic ataxia, or similar

- Pre-existing uncontrolled cardiac disease, signs of cardiac failure, or rhythm
disturbances requiring therapy

- Myocardial infarction within the past 12 months

- Congestive heart failure

- Complete bundle branch block

- New York Heart Association (NYHA) class III or IV heart disease

- Known allergic reactions on study medication

- Cardiac pacemaker

- Disease that would preclude chemoradiation or deep regional hyperthermia

- Any metal implants (with exception of non-clustered marker clips)

- Psychological, familial, sociological, or geographical condition that would preclude
study compliance

- Patients deemed technically unsatisfactory for deep regional hyperthermia

- Cardiac symptoms (> NCI CTCAE Grade 1) due to pretreatment with fluoropyrimidines

- Neurological symptoms (> NCI CTCAE Grade 1) due to pretreatment with oxaliplatin

- Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or
glucose-galactose malabsorption

- Oral anticoagulation

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility rate (i.e. rate of patients not experiencing dose-limiting toxicity [DLT])

Outcome Time Frame:

Participants will be followed for the duration of therapy and for 6 weeks after the last study treatment dose (approximately 11 to 12 weeks)

Safety Issue:

Yes

Principal Investigator

Oliver Ott, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Strahlenklinik, Universitätsklinikum Erlangen

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

ESHO201107/001

NCT ID:

NCT01716949

Start Date:

September 2012

Completion Date:

April 2020

Related Keywords:

  • Rectal Cancer
  • rectal cancer
  • recurrent rectal cancer
  • hyperthermia
  • radiation
  • chemoradiation
  • 5-FU
  • capecitabine
  • oxaliplatin
  • Rectal Neoplasms
  • Fever

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